Floor Speech
Mr. Speaker, this is an important day for American consumers, thanks to the legislation the House is about to pass, the Food and Drug Administration will have the financial resources and authorities necessary to ensure patients have timely access to safe and effective therapies.
First and foremost, this bill is about drug safety. In order to empower the F.D.A. to protect the public from harmful drugs, we're giving the agency new authority to compel important labeling changes. This is a significant improvement over current policy where F.D.A. must haggle with drug companies in protracted negotiations that put patients and consumers at risk.
Under this bill, F.D.A. will also be better equipped to force drug manufacturers to fulfill their responsibility to the American public and complete post-market study commitments, which are critical to ensuring that a drug is safe.
In addition to these important new authorities, this bill authorizes the collection of $225 million in new user fees, a significant increase in the amount of funds dedicated for the use of drug safety activities.
The F.D.A. Revitalization Act also provides for commonsense improvements to our nation's food safety system, such as more stringent ingredient and labeling standards, establishment of an adulterated food registry and improvements in public notifications.
Patients will be happy to know that the bill before us also requires greater transparency of drug makers by calling for clinical trials to be registered in a database monitored by the National Institutes of Health, along with basic results data. As we saw with the case of Avandia, making this information available to patients, providers and researchers is critical to uncovering potential harmful effects of a drug.
And under this legislation, the public will also have greater access to internal documents that F.D.A. used in its review of a drug application. We also secure F.D.A. scientists' right to publish by requiring the Secretary to establish clear policies on the timely clearance of articles written by F.D.A. employees.
And, finally, Mr. Speaker, this bill would make significant progress in reducing the number of conflicted experts who serve on advisory committees.
Mr. Speaker, I'm proud to say that this bill re-authorizes two very important programs for our nation's children: the Best Pharmaceuticals for Children Act and the Pediatric Research and Equity Act. These programs have been crucial in the successful cultivation of important research used by doctors and parents to better determine what kinds of drug therapy is safest and most appropriate for a child patient.
In addition to the two existing programs, we're creating a new program that will help provide device manufacturers with greater incentives to conduct research and development of pediatric devices.
Combined, these three bills would strengthen the research being done on pediatric uses of drugs and devices and will make sure that our nation's children have access to the medicines and therapies they need to grow up healthy and strong.
And, finally, this bill re-authorizes two critically important user fee agreements with respect to prescription drugs and medical devices. These programs provide F.D.A. with the necessary resources to review applications in a timely manner so patients who rely on new and improved drugs and devices don't have to go without. In addition to reauthorizing these existing user fee programs, this bill would establish a new user fee for the specific purpose of reviewing direct to consumer advertising.
I want to commend Mr. Dingell, our ranking Member Mr. Barton, Mr. Deal and all the members here, Mr. Waxman, Ms. Eshoo, Mr. Markey. Their leadership on these issues has been unwavering and it is to their credit that we have a bill on the floor today.
This is a great victory for American consumers that will make tremendous strides in empowering the F.D.A. and restoring public confidence in its ability to protect the public health, and I would urge my colleagues to vigorously support it. |
